Safety Study of EMD 72000 in Combination With ECX (Epirub... | NCT00113581

Studies
Safety Study of EMD 72000 in Combination With ECX (Epirubicin, Cisplatin and Capecitabine) in Oesophagogastric Cancer

NCT00113581

Sponsor

Merck KGaA, Darmstadt, Germany

Status

Completed

Last Update Posted

Feb 19, 2014Estimated

Enrollment

Phase

Phase 1

Conditions

Esophageal Cancer
Gastric Cancer

Interventions

EMD 72000 (matuzumab) + ECX

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

May 2006Actual

Completion Date

Jan 2007Actual

First Submitted Date

Jun 9, 2005

First Submission Date that Met QC Criteria

Jun 9, 2005

First Posted Date

Jun 10, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2014

Last Update Posted Date

Feb 19, 2014Estimated

Description Module

Brief Summary

The main purpose of this study is to test the safety and tolerability and effectiveness of a new treatment, EMD 72000 (matuzumab), for advanced oesophagogastric cancer in combination with the chemotherapy regimen ECX (epirubicin, cisplatin and capecitabine).

In addition the study will look at pharmacokinetic (how the the body takes up the drug) and pharmacodynamic parameters (what the drug does in the body).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
EMD 72000 (matuzumab) + ECX	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability

Secondary Outcomes

Measure	Description	Time Frame
Pharmacodynamic parameters
Pharmacokinetic parameters
Response rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced, recurrent or metastatic gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
EGFR positive tumor
KPS greater than 60
Normal cardiac function
Adequate liver and bone marrow function
GFR greater than 60 ml/minute

Exclusion Criteria:

Previous chemotherapy
Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrythmias
Clinically significant ECG or cardiac history
Radiotherapy or surgery within last 4 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Cunningham, Professor	The Royal Marsden Hospital, Sutton, UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Royal Marsden Hospital		London			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms
D013274	Stomach Neoplasms
C562730	Adenocarcinoma Of Esophagus

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C520777	matuzumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided